Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
This study has been completed.
Information provided by:
Teva Pharmaceuticals USA
First received: January 30, 2009
Last updated: September 1, 2009
Last verified: September 2009
This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
||Randomized, Two-Way Crossover, Single-Dose, Fasting Bioequivalence Study of Lamotrigine 1 x 200 mg Tablet
Primary Outcome Measures:
- Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 120 hour period ] [ Designated as safety issue: No ]
- AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 120 hour period ] [ Designated as safety issue: No ]
- AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 120 hour period ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2002 (Final data collection date for primary outcome measure)
Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
200 mg Tablet
Active Comparator: Lamictal®
Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
200 mg Tablet
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects will be females and/or males, non-smokers, 18 years of age and older.
- Female Subjects will be post-menopausal or surgically sterilized.
- Post-menopausal status is defined as absence of menses for the past 12 months,
- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive urine drug screen at screening.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.
- Subjects with BMI ≥30.0.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
- History of allergic reactions to lamotrigine.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid, use of an investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products )including natural products, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
- Less than 300 mL of whole blood within 30 days or
- 300 mL to 500 mL of whole blood within 45 days or
- more than 500 mL of whole blood within 56 days.
- Positive alcohol breath test at screening.
- Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
Additional exclusion criteria for female subjects only:
- Breast feeding subjects.
- Positive urine pregnancy test at screening (performed on all females).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834561
|Sainte-Foy, Quebec, Canada, G1V 2K8 |
Teva Pharmaceuticals USA
||Benoit Girard, MD
No publications provided
||Teva Pharmaceuticals USA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 30, 2009
|Results First Received:
||June 30, 2009
||September 1, 2009
||Canada: Ethics Review Committee
Keywords provided by Teva Pharmaceuticals USA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014
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